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Recall Observatory FDA recall evidence

Device product

smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081

Z-0095-2022

March 10, 2020

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 88667
Status
Terminated
Classification
Class II
Quantity
10620 units
Official record key
device-enforcement:Z-0095-2022

Official wording

Reason: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

Code information: All codes

Distribution pattern: Austria, France, Germany, Great Britain, and Saudi Arabia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.